Module 1 Norwegian Regulations for use of animals in experiments

Module 1: National legislation - NORWAY

National and EU laws and guidance that regulate the scientific use of animals in

Norway.

Relevant laws, regulations and guidelines

Animal Welfare Act («Lov om dyrevelferd»)

Regulation on the Use of Animals in Research (Norw: “Forskrift om bruk av dyr i

forsøk”)

Norway has also entered into international agreements undertaken to adhere to the EU

Laboratory Animals Directive (2010-63) and the Council of Europe Convention on Laboratory

Animals (ETS 123).

The Animal Welfare Act applies for all issues that affect the welfare of vertebrates,

cephalopodes, cyclostomata, decapodes and honey bees. § 13 cover animals used in

research, education and medical testing.

The Regulation on the Use of Animals in Research applies especially for use of animals in

research, education and testing.

The following issues are covered by the Regulation on the Use of Animals in Research.

Scope of the regulation - § 1

Area of application - §§ 2, 3

Definitions - § 4

Approvals

Approvals of institutions for animal experiments- §§ 5, 12

Approval and Application of animal experiments - §§ 6, 7

Module 1 Norwegian Regulations for use of animals in experiments

Project summary - § 8

Compliance with the principles of the 3Rs - § 9

Purpose of the study - § 10

Methods, test strategies and endpoints - §11

Ban of certain experiments - § 13

Anesthesia and analgesia - § 14

Termination of experiments - § 15

Euthanasia and killing - § 16

Reuse of animals - § 17

Rehoming of animals - § 18

Endangered species - § 19

Primates - § 20

Animal bred for purpose - §22

Stray animals of domestic species - § 23

Demands to competence - § 24

Named persons with special responsibility for oversight - § 25

Animal welfare body - § 26

Named veterinarian or fish health specialist - § 27

Responsibility of primary investigator - § 28

Housing and care - § 28

The physical plant and equipment - § 30

Recordkeeping - § 31

Records for dogs, cats and primates - § 32

Marking of dogs, cats and primates - § 33

Breeding plan for primates - §34

Documentation - § 35

Annual report - § 36

Administrative issues - §§ 37-41

For institutions that are accredited by AAALAC International the following guidelines will also apply

The Guide to the Care and Use of Laboratory Animals

European Convention for the Protection of Vertebrate Animals Used for Experimental and

Other Scientific Purposes, Council of Europe;(ETS 123)

Guide for the Care and Use of Agricultural Animals in Research and Teaching (if such species

are relevant)

Related regulations

Other laws and regulations for animals. There are several other regulations that apply for

different activities that might influence animal welfare and are therefore relevant for

animals in research. Some examples are:

Module 1 Norwegian Regulations for use of animals in experiments

o Regulations on Commercial Transport of Animals («Forskrift om næringsmessig

transport av dyr»)

o Regulation on Killing of Animals

o Regulation on Import and Export of Animals

o Veterinarians and Other Animal Health Personnel Act («Lov om veterinærer og annet

dyrehelsepersonell»)

Other laws and regulations for animal experiments and work with animals. There are also

other laws and regulation related to animal experiments like

o Regulation of Drugs («Forskrift om legemidler»)

o Gene modified animals (GMO)

Gene Technology Act («Lov om framstilling og bruk av genmodifiserte

organismer m.m. genteknologiloven»).

Regulation of Enclosed use of GM Animals («Forskrift om innesluttet

bruk av genmodifiserte dyr»)

Regulation on Enclosed use of GM Microorganisms («Forskrift om

innesluttet bruk av genmodifiserte mikroorganismer»)

Regulation on Marking, Transport, Import and Export of GMO

(«Forskrift om merking, transport, import og eksport av

genmodifiserte organismer»)

o Health and safety regulations

Work Environment Act («Arbeidsmiljøloven»)

Regulation on Work Practice («Forskrift om utførelse av arbeid»)

Regulation for Work Places («Arbeidsplassforskriften»)

Regulation on Preventive Measures and Limits («Forskrift om tiltaks-

og grenseverdier»)

Radiation Protection Act («Lov om strålevern og bruk av stråling»)

Regulation on Radiation Protection (“Strålevernforskriften”)

Regulation on Use of Humane Cells and Tissues (“Forskrift om håndtering

av humane celler og vev»)

o Regulations for wildlife research

Catching of Wildlife for Scientific Purposes

The Svalbard Environmental Protection Act

Regulation for Motor Traffic in Svalbard

Convention on International Trade in Endangered Species of Wild

Flora and Fauna (CITES)

o Administrative laws and regulations

Administration Act (Forvaltningsloven)

Public Transparency in Administrasjon Act (offentlighetsloven)

Module 1 Norwegian Regulations for use of animals in experiments

Authorization needed before acting as user, breeder or supplier of

laboratory animals - authorization required for projects and individuals.

Institutions (User, breeder or supplier) Institutions (User, breeder or supplier of laboratory animals)

must be approved by Mattilsynet (The Norwegian Food Safety Authority). Both the physical plant as

wells as organization of personnel and activities must be approved.

Institutions must:

Define an Animal welfare body (§26)

• Name persons with special responsibility for oversight (Person med særlig kontrollansvar –

PMSK) (§26)

• Develop system and policy documents

Annual report of animal use the previous year must be submitted within March 1 to

Mattilsynet.

Competence: Applicant and participants Must as a minimum fulfill training program in

accordance with Appendix E of the regulation that covers (§24):

1. National regulation of the use of animals in research

2. Ethics related to relationship between humans and animals, intrinsic value of life and

arguments for and against use of animals in research

3. Basic relevant biology, anatomy, physiology, reproduction and genetics for the

species in question.

4. Animal welfare, care and enrichment

5. Species specific handling

6. Animal health and hygiene

7. Recognition of species specific signs of fear, pain or other harm

8. Anesthesia, analgesia and euthanasia

9. Humane endpoints

10. 3R

11. Design of experiments

Persons must maintain and document competence through continuous practice and

education.

Persons designing experiments (Function B) must have received adequate training in the

scientific discipline relevant to the work to be performed, and have specific knowledge of

the relevant animal species' biology, including their physiological and behavioral needs.

Persons who carry out procedures (function A), care of animals (Function C) or kills animals

(Function D) shall be supervised when they perform tasks until they have demonstrated that

Module 1 Norwegian Regulations for use of animals in experiments

they master the necessary skills. It must been documented what species and procedures the

candidate has been trained in and master so that they can work independently.

Mattilsynet considers that FELASA C course recommendations for the teaching of theory

meets requirements for theoretical training for function A = those who perform experiments

and function B = those designing procedures and projects.

Those who have already FELASA C courses must:

Familiarize themselves with the new Norwegian regulations of July 1 2015

Must relate to the requirement for continuing education

Those who have a FELASA C course from another country must take a course module in

national Norwegian regulations.

Persons with special oversight responsibility are to ensure that everyone working with

animals in his/her project meets the requirements of education and training, and also

constantly updating and training.

It is each researcher's responsibility to make sure your CV is up to date in relation to the

requirements for continuous updating and training in laboratory animal science.

Individual projects: Permission to use animals in research must be obtained from

Mattilsynet after application in FOTS («Forsøksdyrforvaltningens tilsyns- og søknadssystem»)

https://asp.gitek.no/fdu/pmws.dll/Login?RestoreSession=r4byycEd0uY28GRD

Some general requirements to projects:

Applicant and participants competence (of all personnel involved)

Public project summary

Information on severity (expected pain and discomfort)

Demonstrate compliance to 3R

Harm-benefit assessment

Animals to be used (number, sex, species)

In addition applicant has to provide information on

Funding body

Planned start and end of experiments

Module 1 Norwegian Regulations for use of animals in experiments

Public access of information

Background and purpose

Rationale for using the chosen animal model.

o If relevant: deviant phenotype that may impact animal welfare

Sedation, analgesia and anesthesia

Calculating number of animals (experimental groups and group sizes)

Methods description

o Preparation of animals

o Procedures

o Monitoring and sampling

o Supervision of animals

o Method for euthanasia

o Criteria for humane endpoints and actions to be taken

Approval can be valid for maximum 4 years. For wildlife experiments max 2 years.

Sources of information and support available.

Lovdata – all Norwegian laws and regulation are available here

o www.lovdata.no

o https://lovdata.no/dokument/SF/forskrift/2015-06-18-761

o https://lovdata.no/dokument/NL/lov/2009-06-19-97

o https://www.regjeringen.no/en/dokumenter/animal-welfare-act/id571

Mattilsynet (the Norwegian Food Safety Authority)

o http://www.mattilsynet.no/dyr_og_dyrehold/dyrevelferd/forsoksdyr

norecopa – the Norwegian national consensus platform for alternatives to use of

animals

o www.norecopa.no

o Q&A from Mattilsynet http://norecopa.no/eu-direktivet-2010/63/eu

Institutional Animal Welfare Body – give advice on several issues

Designated veterinarian in the institution - give advice on several issues

Other sources

Rådet for dyreetikk (Advisory board for animal ethics, Ministry of agriculture) –

disciss ethical issues with regard to animal use in general

o http://www.radetfordyreetikk.no/

The National Committee for Research Ethics in Science and Technology (NENT)

o https://www.etikkom.no/en/In-English/Committee-for-Research-Ethics-in-

Science-and-Technology/

Module 1 Norwegian Regulations for use of animals in experiments

Personnel mentioned in Article 24, 25 and 26, their statutory duties and

other responsibilities under the Norwegian legislation.

Specific requirements for personnel (Article 24 in the EU Directive 2010/63)

According to §§ 24 and 25 in the regulation on animal experimentation, personnel working

with animals at breeders, suppliers and users shall have the minimum competence described

in Appendix E before they start to plan/design experiments, care for or euthanize animals.

The minimum demands in Appendix E are:

1. The regulation of animal experimentation

2. Ethics related to the relationship between humans and animals, the intrinsic value

of life and arguments for and against use of animals for scientific purposes.

3. Basic and relevant species specific biology related to anatomy, physiology,

breeding, genetics and changes in genetics

4. Animal behavior, housing, care and environmental enrichment.

5. Species specific handling methods

6. Animal health procedures and hygiene

7. Species specific signs of fear, pain or other negative impact for the most common

research animals.

8. Anesthesia, analgesia and euthanasia

9. Use of humane endpoints

10. Demands to replacement, reduction and refinement

11. Design of experiments (if relevant)

Persons responsible for planning experiments (function B) shall be adequately educated in

the scientific field they work within and have specific competence in the relevant species

biology, physiology and behavioral needs of the species in question.

Persons performing procedure (Function A), animal caretakers (function C) or killing animals

(Function D) shall be supervised until they demonstrate that they master the necessary skills.

The institution must describe written procedures that safeguard these requirements.

Named persons with special responsibility for oversight (PMSK) shall:

• Control animal welfare and caretaking

• Make sure that all staff have access to relevant information about the species in

question

• Safeguard that persons working with animals fulfill demands to competence.

Module 1 Norwegian Regulations for use of animals in experiments

Designated veterinarian (Article 25 in EU directive 2010/63)

According to § 27 in the Regulation on Animal Experimentation all institutions shall have a

named veterinarian or fish-health specialist1 with special competence in laboratory animal

medicine.

The veterinarian or fish-health specialist shall:

• Give advice on animal welfare and treatment

• Evaluate if the nimal is fit to live a good life after an experiment is terminated

• Evaluate if an animal can be used in another experiment after the first is terminated

• Evaluate if an animal is fit for rehoming after termination of an experiment:

o If an animal is rehomed a veterinary journal with veterinary medicine and

social issues for the animal shall follow the animal

• Give advice to the Animal Welfare Body (preferably the veterinarian should be a

permanent member of the animal welfare body)

• Any deviation from housing conditions defined in the regulation in appendix F, part B

“Species specific demands of animal experimentation” must be based on a

veterinary-medical evaluation

Animal welfare Body (Article 26 in EU directive 2010/63)

According to § 26 in the Regulation of Animal Experimentation the institution shall have an

animal welfare body (“Dyrevelferdsenhet”)

The animal welfare body shall

• Give advice in acquiring, housing, care and use of animals

• Give advice on compliance with the 3Rs (Replacement, Reduction and Refinement)

• Provide information on technical and scientific progress on replacement, reduction

and refinement

• Develop and review internal operation routines to monitor, report on an follow up

animal welfare issues

• Monitor how experiments impact animal welfare

• Identify and give advice on factors that contribute to further replacement, reduction

and refinement

• Give advice for rehoming of animals

1 Fish-health specialists are persons who have completed an Integrated Master Programme in Aquamedicine

and are authorized as by Mattilsynet. Fish-health specialists are only competent for this function as long as the

institution only keeps aquatic animals but not sea ling mammals

Module 1 Norwegian Regulations for use of animals in experiments

A recordkeeping of all advices and decisions made by the Animal welfare body shall be

stored for a minimum of 3 years and be available on request from Mattilsynet.

The Animal welfare body shall as a minimum consist of the person with special responsibility

for oversight. If the institution uses animals for research the animal welfare body shall have

at least one member with relevant scientific knowledge.

The roles and responsibilities of the local animal welfare bodies and the

national committee for the protection of animals used for scientific

purposes.

The role and responsibility of the local Animal Welfare Body described above.

Mattilsynet (the Norwegian Food Safety Authority) is the national authority responsible for

• Approving and inspecting users, suppliers and breeders (Physical plant and

organization)

• Approve applications for animal experiments

• Give permission to other people than veterinarian and fish health specialist to

administer total or local anesthesia on the condition that they have received training

and this must be clear from the project description and project approval.

• Withdraw or suspend approval if the trial is not conducted in accordance with the

regulation or approval

• Authority to approve and exempt from the ban against cardiac puncture in

anesthetized animals when not a part of a terminal procedure.

• Authority to approve other euthanasia methods than described in the regulation

appendix C

• Authority to approve reuse of animals

• Authority to approve the use of animals that are not bred for experimental purposes

• Authority to approve the use of strayed domestic animals

• Authority to approve reuse of animals

• Review record from the animal welfare body

• Review animal journals

• Approve exemption for housing conditions

• Approve single housing of animals

Responsible for compliance at an establishment and how this responsibility may be

exercised (e.g. through the local Animal Welfare Body.

The person responsible for compliance of the regulation should be a person with adequate

influence on resources.

Module 1 Norwegian Regulations for use of animals in experiments

Procedure regulated under National legislation (minimum threshold of

pain, suffering, distress or lasting harm).

The Regulation of Animal Experimentation apply for

Experiments i.e. any use of animals for scientific or educational purpose and for medical

purposes that can cause pain, fear, lasting harm or other negative impact larger or equal to

injection of a needle using good veterinary practice. This also applies for any interventions

that cause animals to be born or hatched as well as establishing or maintaining gene

modified animal colonies with similar negative impact for the animals. An experiment might

also be a work program with a defined scientific aim and consisting of one or more

procedures. For animals that are not bred or held for the use of organs or tissues can be

used for scientific purposes, euthanasia of these animals is not considered as experiments.

Field Experiments i.e. an experiment taking place outside an approved facility.

Facility: i.e. Plant, building, group of buildings or other rooms, including those that are not

enclosed and mobile installation with its interior and equipment.

Breeder: i.e. physical or judicial person that breed species listed in Appendix D with the

purpose of using them, or their organs or tissues for scientific purposes.

Supplier: i.e. physical or judicial person, exempt from breeders that supply animals for use in

experiments or organ/tissues for scientific purposes

User: i.e. physical or judicial person who use animals in experiments

Endangered species: i.e. species that are categorized as critically endangered or vulnerable

in the Norwegian red list.

Primary responsibility for animals undergoing procedures.

Responsibility for animals in experiments. The primary investigator/project leader (project

license holder) is responsible for the animals in their experiments.

He/she has to safeguard that

a. Cause of any unnecessary pain, fear, lasting harm of other negative impact is

eliminated as soon as possible

b. Experiments are performed in exact accordance with the approval and decision made

by Mattilsynet

c. Any deviations and compensatory actions are recorded.

Module 1 Norwegian Regulations for use of animals in experiments

Species, including respective stages of development that are included in the

scope of the Directive / National law.

The Regulation apply for

Live vertebrates

Decapods

Cephalopods

Honey bees

The regulation also apply for early life stages if the animal is to be allowed to live beyond

that stage of development and, as a result of the procedures performed, is likely to

experience pain, suffering, distress or lasting harm after it has reached that stage of

development including mammal fetuses in the last trimester and larvae of vertebrates that

nurture themselves (after start feeding)

The following species must be bred for scientific purposes.

1. Mice (Mus musculus)

2. Rat (Rattus norvegicus

3. Guinea pig (Cavia porcellus)

4. Syrian/golden hamster (Mesocricetus auratus)

5. Chinese hamster (Cricetulus griseus)

6. Mongolian gerbil (Meriones unguiculatus)

7. Rabbit (Oryctolagus cuniculus)

8. Dog (Canis familiaris)

9. Cat (Felis catus)

10. All species of non-human primates

11. Frogs (Xenopus (laevis, tropicalis), Rana (temporaria, pipiens))

12. Zebrafish (Danio rerio)

Circumstances in which animals under the scope of the regulatin should be

humanely killed or removed from the study to receive veterinary

treatment.

Animal must be killed

If unforeseen pain cannot be relieved by painkillers

Humane endpoints

Death as endpoint shall be avoided and replaced by earlier humane endpoints. If death is

unavoidable, the experiment shall be designed so that

Module 1 Norwegian Regulations for use of animals in experiments

a. Death is caused for as few animals as possible

b. Duration and intensity of any harm is minimized

c. A pain-free death is safeguarded as long as possible

Any experiment with death as endpoint is classified as severe.

Rehoming of animals after experiments must only be made after veterinary evaluation of the

animals.

Describe the legislative controls over the killing of animals bred or used for

scientific procedures.

Killing and all handling related to the act of killing animal shall not cause unnecessary pain,

fear or other harm and have to be performed taking animal welfare concerns.

Killing methods are described in annex C to the regulation

Other methods can only be used after approval from Mattilsynet

o On unconscious animals

o When purpose of experiments require a similar killing methods as used for farm

animals

Death must be confirmed by either

Confirmation of circulatory arrest

Destruction of brain

Dislocation of neck

Outbleeding

Confirmation of rigor mortis